BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL

    K Number: K063209 · Decision Mar 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    9
    Review Days
    149

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    Basic Information

    Device Name
    HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
    K Number
    K063209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thermo Electron OY
    Date Received
    October 23, 2006
    Decision Date
    March 21, 2007
    Product Code
    LCP
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LCP Assay, Glycosylated Hemoglobin

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    K063838 LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
    K063086 TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
    K063150 COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
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